Melissa A. Wong

Melissa A. Wong is an attorney in Holland & Knight's Boston office and is a member of the firm's national Healthcare & Life Sciences Industry Group, with a focus on managed care and federal healthcare programs, including Medicare and Medicaid, as well as prescription drug coverage and reimbursement issues.

Ms. Wong represents a diverse group of healthcare industry clients, including health plans and managed care organizations (MCOs), pharmaceutical and medical device manufacturers, pharmacy benefit managers (PBMs), public-private state Medicaid agencies, third-party administrators (TPAs) and utilization review (UR) entities, insurance brokers and field marketing organizations, and traditional healthcare providers and suppliers, including physician groups and pharmacies (retail, specialty, long-term care and mail order).

Ms. Wong has accumulated more than 10 years of regulatory and technical experience in government healthcare programs, including Medicare and Medicaid, Medicare Advantage, Medicare Part D, Managed Medicaid and the Children's Health Insurance Program (CHIP). She advises clients on sophisticated issues related to these programs in a variety of regulatory and transactional settings, including in mergers and acquisitions, client services transactions, private equity investment, representations and warranties (R&W) insurance underwriting, lending arrangements, government and payer audits and investigations, and interactions with federal and state government agencies. In addition, Ms. Wong counsels pharmaceutical manufacturers, pharmacy benefit managers and other stakeholders on drug coverage, pricing and reimbursement matters and emerging trends in this field, including the growing use of value-based purchasing arrangements. In addition, Ms. Wong has experience in the development and implementation of many companywide compliance programs tailored to Managed Medicare and Qualified Health Plan compliance obligations as well as targeted compliance efforts to guide sales and marketing activities conducted by health plans and their downstream entities, healthcare providers and pharmaceutical manufacturers.

Ms. Wong is active as a leader in the American Health Law Association and the Asian American Lawyers Association of Massachusetts. She also serves as the chair of the Board of Directors of Massachusetts Asian and Pacific Islanders (MAP) for Health, a nonprofit organization promoting health access and outreach to Asian-American communities in Massachusetts. In addition, Ms. Wong is a member of the Hiring Committee for Holland & Knight's Boston office.

Representative Experience

• Represented Medicare Part D sponsors before the Centers of Medicare and Medicaid Services (CMS), state departments of insurance and Administrative Law Judge (ALJ) hearings on various regulatory and administrative issues, including federal and state "any willing pharmacy" requirements, Managed Medicare non-interference and preemption issues, and prescription drug coverage determination appeals
• Serve as primary regulatory counsel to public-private government agencies administering state Medicaid and Children's Health Insurance Program (CHIP) programs; drafted and negotiated statewide Medicaid managed care organizations (MCO) and Medicare D-SNP model agreements and subsequent amendments, as well as enrollment broker, pharmacy benefits management (PBM) and prescription drug rebate administrator agreements; developed state Medicaid program's drug formulary and coverage exceptions infrastructure and procedure, including the drafting of state regulations governing this process
• Recruited as an on-site legal and compliance resource for a 6-month engagement at a Medicare Part D plan to oversee process improvements related to coverage determinations and appeals processes; managed consultant team and implemented new training modules, policies and procedures, and operational changes; continue to conduct ongoing monitoring and advice related to the coverage and review of prescription drugs under Medicare Part B, Medicare Part D and Medicaid
• Authored several research white papers for pharmaceutical manufacturer industry group that analyzed legal and regulatory barriers, including those related to the federal anti-kickback statute and Medicaid best price reporting, to value-based purchasing arrangements and alternative payment mechanisms for higher-cost specialty drugs and gene therapies; drafted and coordinated the submission of comments to CMS and proposed rules and working legislation to help promote the use of value-based purchasing in Medicare and Medicaid
• Advise both health plans and providers on complex data reporting issues under Medicare Advantage, Part D and Medicaid, including the submission and restatement of Part D prescription drug event (PDE) data and direct and indirect remuneration (DIR) reporting and the classification of expenditures for medical loss ratio (MLR) purposes; assist clients in responding to compliance incidents, payer audits and overpayment recoveries that implicate these issues
• Assist healthcare providers and pharmaceutical manufacturers in the design of patient and provider assistance programs to ensure compliance with anti-kickback and beneficiary inducement laws and regulations; developed training modules, policies and procedures, and business tools to guide sales and marketing activities conducted by pharmaceutical sales forces
• Advise third-party administrators (TPAs) and utilization review (UR) organizations in ongoing state licensing and regulatory matters; coordinated the preparation and submission of dozens of new and renewal TPA and UR license applications in every state that regulates such activities